3-Month Trial Observation of A1c Change

Type 2 Diabetes Clinical Trial

Official title:

Assessment of an Internet Blood Glucose Management Program in a Chronic Care Hospital

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01415271
• Other study ID #: Point Grey Trial
• Status: Terminated
• Phase: N/A
• First received: August 10, 2011
• Last updated: August 10, 2015
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2015
• Source: Endocrine Research Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

The incidence of type 2 diabetes in long term care facilities has been approximated at 25% with barriers to treatment including untimely access to a specialist and improper/poor adherence to insulin regimes. This 3 month trial will investigate the efficacy of improving overall glycemic control by using an internet blood glucose reporting system to facilitate bi-weekly consultations between long term care facility patients with type 2 diabetes and an endocrinologist.

Description:

Purpose: This project will investigate the benefits (as measured by change in the primary outcome measure hemoglobin A1c) of bi-weekly reporting of blood sugar values for patients with type 2 diabetes in long term care facilities.

Hypothesis: Our hypothesis is bi-weekly reporting will result in a reduction in A1c after 3 months.

Justification: Elevated A1c values increase risk of health complications for people with type 2 diabetes.

Objectives: Improved type 2 diabetes management for patients in long term care facilities.

Research Methods: Patients who meet the inclusion / exclusion criteria and are interested in participating in the study will self-identify to the research coordinator. Consent will be done in person with any questions answered. Strips and blood glucose meters will be provided. Blood glucose values and testing frequency will be recorded using the internet reporting system Heath-e-Connect. HbA1c, serum creatinine and demographic data will be collected at 0 and 3 months to determine effect of bi-weekly remote communication of blood glucose with an endocrinologist.

Statistical Analysis: HbAlc values at 0 and 3 months will be compared using an unpaired t-test to measure the effect of the intervention

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Type II diabetes mellitus patients at Point Grey Private Hospital

• Trained in self-blood glucose monitoring

• Willingness to test blood glucose levels a minimum of 3 times daily

• Willingness to be trained on IBGMS

Exclusion Criteria:

• Patients with medical conditions that may affect their study participation or results will be excluded.

• Patients currently being treated with steroid medication

• Patients that have impaired liver function

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Other:
• Internet Communication
bi-weekly communication of blood sugars using an internet platform between patients with type 2 diabetes and an endocrinologist

Locations

Country	Name	City	State
Canada	Endocrine Research Society	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Endocrine Research Society

Country where clinical trial is conducted

Canada, 

References & Publications (7)

American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. — View Citation

Austin MM, Haas L, Johnson T, Parkin CG, Parkin CL, Spollett G, Volpone MT. Self-monitoring of blood glucose: benefits and utilization. Diabetes Educ. 2006 Nov-Dec;32(6):835-6, 844-7. — View Citation

Clement M and Leung F. Diabetes and the Frail Elderly in Long-term Care. Can J Diabetes. 2009;33(2):114-121.

Hirsch IB, Bode BW, Childs BP, Close KL, Fisher WA, Gavin JR, Ginsberg BH, Raine CH, Verderese CA. Self-Monitoring of Blood Glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research. Diabetes Technol Ther. 2008 Dec;10(6):419-39. doi: 10.1089/dia.2008.0104. Review. — View Citation

Karter AJ, Ackerson LM, Darbinian JA, D'Agostino RB Jr, Ferrara A, Liu J, Selby JV. Self-monitoring of blood glucose levels and glycemic control: the Northern California Kaiser Permanente Diabetes registry. Am J Med. 2001 Jul;111(1):1-9. — View Citation

The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993 Sep 30;329(14):977-86. — View Citation

Tildesley HD, Mazanderani, AB, Chan, JHM et al. Efficacy of A1c Reduction Using Internet Intervention in Patients with Type 2 Diabetes Treated with Insulin. Can J Diabetes. 2011; 35(3): 250-253.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Hemoglobin A1c will be measure at 0 and 3 months to determine the efficacy of the internet blood glucose monitoring system as measured by change in glycemic control.	0 and 3 months	No
Secondary	Staff satisfaction	Measure of hospital staff satisfaction of using the Health-e-Connect platform to help patients communicate with an endocrinologist	3 months	No
Secondary	Frequency of Self-Monitoring	Measure the frequency of blood glucose self-monitoring of the patients by collecting the total number of tests using the provided meter.	3 months	No
Secondary	unplanned hospitalizations	A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours	3 months	Yes